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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Farmers Insurance
Queensland Health
McKinsey
Daiichi Sankyo
Express Scripts
Fish and Richardson
Argus Health
Chubb

Generated: July 19, 2018

DrugPatentWatch Database Preview

Insulin detemir recombinant - Generic Drug Details

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What are the generic drug sources for insulin detemir recombinant and what is the scope of insulin detemir recombinant freedom to operate?

Insulin detemir recombinant
is the generic ingredient in five branded drugs marketed by Novo Nordisk Inc and is included in one NDA. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin detemir recombinant has two hundred and twenty patent family members in thirty countries.

There are forty drug master file entries for insulin detemir recombinant. Four suppliers are listed for this compound.
Pharmacology for insulin detemir recombinant
Ingredient-typeInsulin
Drug ClassInsulin Analog
Medical Subject Heading (MeSH) Categories for insulin detemir recombinant
Synonyms for insulin detemir recombinant
169148-63-4
201305-44-4
270588-25-5
29(sup B)-(N(sup 6)-(1-Oxotetradecyl)-L-lysine)-(1(sup A)-21(sup A)),(1(sup B)-29(sup B))-insulin (human)
29(sup B)-(N(sup 6)-Myristoyl-L-lysine)-30(sup B)-de-L-threonineinsulin (human)
29B-(N6-Myristoyl-L-lysine)-30B-de-L-threonineinsulin (human)
4FT78T86XV
CHEMBL2104391
D0QE5U
Insulin detemir
Insulin detemir [USAN:INN:BAN]
Insulin-detemir
Levemir
Levemir Flexpen
Levemir Innolet
Levemir Insulin
Levemir Penfill
NN 304
NN-304
NN304
UNII-4FT78T86XV

US Patents and Regulatory Information for insulin detemir recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc LEVEMIR INNOLET insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-003 Jun 16, 2005 DISCN No No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Novo Nordisk Inc LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for insulin detemir recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc LEVEMIR PENFILL insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-004 Jun 16, 2005 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc LEVEMIR PENFILL insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-004 Jun 16, 2005 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for insulin detemir recombinant

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,011,007 Acylated insulin ➤ Sign Up
6,869,930 Acylated insulin ➤ Sign Up
6,235,004 Injection syringe ➤ Sign Up
6,582,404 Dose setting limiter ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for insulin detemir recombinant

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00160 Netherlands ➤ Sign Up PRODUCT NAME: INSULINE DETEMIRUM; NAT. REGISTRATION NO/DATE: EU/1/04/278/001EU/1/04/278/002EU/1/04/278/003EU/1/04/278/005EU/1/04/278/004EU/1/04/278/006EU/1/04/278/007EU/1/04/278/008EU/1/04/278/009 2004010601; FIRST REGISTRATION: 563705637156372EU/1/04/278/001 T/M -/009 2003101110
13/034 Ireland ➤ Sign Up APPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE 2013/034 IN JOURNAL NO. 2325 OF 25/01/2017 UNDER THE HEADING APPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE, SPC NO. 2013/034 SHOULD HAVE APPEARED AS FOLLOWS, NOVO NORDISK A/S NOVO ALLE, 2880 BAGSVAERD, DENMARK (20/12/2016) PATENT NO: EP2107069; NOVEL INSULIN DERIVATIVES PRODUCT: INSULIN DEGLUDEC MARKET AUTHORISATION: EU: EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 (21/01/2013) ORIGINAL SPC EXPIRY DATE: 22/01/2028 1127 DESIGNS REGISTERED UNDER THE INDUSTRIAL DESIGNS ACT, 2001
/2005 Austria ➤ Sign Up PRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 50:50; REGISTRATION NO/DATE: EU/1/00/142/011 - EU/1/00/142/016 20051005
C0009 France ➤ Sign Up PRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/258/001 DU 20040927; REGISTRATION NO/DATE AT EEC: EU/1/04/285/001 DU 20040927
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Daiichi Sankyo
Johnson and Johnson
Fish and Richardson
Cerilliant
Fuji
Moodys
US Department of Justice
Deloitte

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.